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Kramer Levin Naftalis & Frankel LLP | USA | 30 Jul 2021

Interchangeable Biosimilars Have Arrived in the U.S.

On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a…
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Hogan Lovells | USA | 16 Feb 2021

No Surprises Act prohibits balance billing, creates arbitration process for out-of-network providers

Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1)…
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Sheppard Mullin Richter & Hampton LLP | USA | 29 Sep 2020

Residential Eviction Protections and California Consumer Financial Protections Pass Muster During 2020 Legislative Session

During the eleventh hour of the 2020 legislative session, the State legislature approved 2 significant bills in response to the COVID-19 pandemic…
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Morrison & Foerster LLP | USA | 9 Sep 2020

Pediatric Exclusivity for Biologics

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with…
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Nexsen Pruet | USA | 18 Aug 2020

It’s time for hospitals to prepare for price transparency

In November 2019, pursuant to an Executive Order issued by President Trump in June 2019, the Centers for Medicare & Medicaid Services (CMS) published…
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Kelley Drye & Warren LLP | USA | 20 Apr 2020

Finding Fevers: FDA Relaxes Rules On Temperature-Detecting Cameras

As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering…
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Hogan Lovells | USA | 25 Mar 2020

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement…
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Ropes & Gray LLP | USA | 24 Mar 2020

Will the Coronavirus Spur Passage of LDT Reform Legislation?

On March 5, 2020, a bipartisan group of legislators introduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2020 in both the U…
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Klein Moynihan Turco LLP | USA | 5 Mar 2020

CBD Cosmetics Advertising Guidelines

When the Agriculture Improvement Act of 2018 (the "Farm Bill") was signed into law in December 2018, it gave the Cannabidiol ("CBD") industry hope…
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Hogan Lovells | USA | 31 Jan 2020

CMS’ 2021 health insurance exchanges proposal shifts pharmaceutical manufacturer copay coupon policy

Rule”), setting forth proposals applicable to qualified health plans (QHPs) offered on health insurance exchanges as well as certain proposals…
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